GENERAL AND PLASTIC SURGERY DEVICES

• Citation: 21 CFR Part 878
• Sections: 105

§ 878.1 Scope.

(a) This part sets forth the classification of general and plastic surgery devices intended for human use that are in commercial distribution.

(b) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for a device under part 807 cannot show merely that the device is accurately described by the section title and identification provision of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required by § 807.87 of this chapter.

(c) To avoid duplicative listings, a general and plastic surgery device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic device) is listed in one subpart only.

(d) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.

(e) Guidance documents referenced in this part are available on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm..

§ 878.3 Effective dates of requirement for premarket approval.

A device included in this part that is classified into class III (premarket approval) shall not be commercially distributed after the date shown in the regulation classifying the device unless the manufacturer has an approval under section 515 of the act (unless an exemption has been granted under section 520(g)(2) of the act). An approval under section 515 of the act consists of FDA's issuance of an order approving an application for premarket approval (PMA) for the device or declaring completed a product development protocol (PDP) for the device.

(a) Before FDA requires that a device commercially distributed before the enactment date of the amendments, or a device that has been found substantially equivalent to such a device, has an approval under section 515 of the act, FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as provided in paragraphs (b) and (c) of this section. Such a regulation under section 515(b) of the act shall not be effective during the grace period ending on the 90th day after its promulgation or on the last day of the 30th full calendar month after the regulation that classifies the device into class III is effective, whichever is later. See section 501(f)(2)(B) of the act. Accordingly, unless an effective date of the requirement for premarket approval is shown in the regulation for a device classified into class III in this part, the device may be commercially distributed without FDA's issuance of an order approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section 515(b) of the act requiring premarket approval for a device, section 501(f)(1)(A) of the act applies to the device.

(b) Any new, not substantially equivalent, device introduced into commercial distribution on or after May 28, 1976, including a device formerly marketed that has been substantially altered, is classified by statute (section 513(f) of the act) into class III without any grace period and FDA must have issued an order approving a PMA or declaring completed a PDP for the device before the device is commercially distributed unless it is reclassified. If FDA knows that a device being commercially distributed may be a “new” device as defined in this section because of any new intended use or other reasons, FDA may codify the statutory classification of the device into class III for such new use. Accordingly, the regulation for such a class III device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution.

(c) A device identified in a regulation in this part that is classified into class III and that is subject to the transitional provisions of section 520(l) of the act is automatically classified by statute into class III and must have an approval under section 515 of the act before being commercially distributed. Accordingly, the regulation for such a class III transitional device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution.

§ 878.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Accordingly, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:

(a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;

(b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or

(c) The device is an in vitro device that is intended:

(1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices;

(2) For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism;

(3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy;

(4) For assessing the risk of cardiovascular diseases;

(5) For use in diabetes management;

(6) For identifying or inferring the identity of a microorganism directly from clinical material;

(7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma;

(8) For noninvasive testing as defined in § 812.3(k) of this chapter; and

(9) For near patient testing (point of care).

§ 878.1800 Speculum and accessories.

(a) Identification. A speculum is a device intended to be inserted into a body cavity to aid observation. It is either nonilluminated or illuminated and may have various accessories.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

§ 878.1820 Software-aided adjunctive diagnostic device for use on skin lesions by physicians trained in the diagnosis and management of skin cancer.

(a) Identification. A software-aided adjunctive diagnostic device for use on skin lesions by physicians trained in the diagnosis and management of skin cancer is a device that uses a software algorithm to analyze optical or other physical properties of a skin lesion and returns a classification of the skin lesion. The device is intended for prescription use by a physician trained in the clinical diagnosis and management of skin cancer ( e.g., a dermatologist) as an adjunctive device to aid in the evaluation of lesions suspicious for skin cancer following identification of a suspicious skin lesion. The device is not intended for use as a standalone diagnostic and is not for use to confirm a clinical diagnosis.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Data obtained from premarket clinical performance validation testing, or a combination of premarket clinical performance validation testing and post-market surveillance (in accordance with paragraph (b)(2) of this section), must:

(i) Demonstrate superior accuracy of device-aided users' diagnostic characterization of the indicated lesions compared to the accuracy of unaided users in the intended patient population and under anticipated conditions of use;

(ii) Include an evaluation of patients across risk factors (including age, body site, skin phototype, and other clinical factors as applicable) that represent the intended patient population under anticipated conditions of use; and

(iii) Include standalone device performance testing that demonstrates the accuracy of the device output relative to ground truth in the intended patient population and under anticipated conditions of use, including the following:

(A) Testing must demonstrate at least 90% sensitivity of the device output for lesions with high metastatic potential, or an alternative clinical consideration must be provided to justify lower sensitivity. Clinical justification must be provided to support the reported specificity.

(B) Lesions must be selected by representative users ( e.g., dermatologists) and a justification must be provided for the quantity and range of mimic lesions per diagnosis.

(C) Justification must be provided to support the determination of ground truth.

(D) Testing must include a representative range of individuals with different risk factors (including age, body site, skin phototype, and other clinical factors as applicable), and analysis of standalone performance must include subgroup analysis by relevant risk factors.

(2) Data obtained from post-market surveillance must demonstrate, in consideration of the premarket data obtained in accordance with paragraph (b)(1) of this section, that the device performs in accordance with paragraph (b)(1) of this section, unless FDA determines, based on the totality of the premarket data, that data from post-market surveillance is not required to demonstrate that the device performs as intended. Such post-market surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with paragraph (b)(1) of this section), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.

(3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including compatibility testing of the device software with specific signal or image acquisition hardware. Testing must include a description of compatible hardware and processes, pre-specified compatibility testing protocols, and dataset(s).

(4) Performance testing must demonstrate device precision, including repeatability and reproducibility of device performance, across operators and challenging use conditions.

(5) Performance testing must demonstrate electromagnetic compatibility, and electrical, mechanical, and thermal safety of any electrical components of the device.

(6) Performance testing must validate reprocessing instructions for reusable components of the device.

(7) Sterilization validation must be conducted for components that must be sterile. Performance testing must also demonstrate continued sterility and package integrity of components that must be sterile, as well as continued device functionality, over the identified shelf life of the device.

(8) The patient-contacting components of the device must be demonstrated to be biocompatible.

(9) Software verification, validation, and hazard analysis must be performed.

(10) A human factors assessment must demonstrate that the device can be safely used by intended users.

(11) Labeling must include:

(i) A summary of standalone and clinical performance testing conducted with the device. The summary must describe performance measures, including sensitivity and specificity, and statistical confidence intervals, as well as performance of the device for all clinically relevant subgroups within the intended patient population;

(ii) A description of the patient population that was used in development or training of the device algorithm;

(iii) Information related to the limitations of device performance or subpopulations for which the device may not perform as expected or for whom the device has not been validated;

(iv) Information needed to facilitate interpretation of all device outputs, and identification of the risks associated with misinterpretation of the device outputs;

(v) A statement that the device is not intended for use as a standalone diagnostic and is not for use to confirm a clinical diagnosis;

(vi) User qualifications needed for safe use of the device, including a description of user training required prior to use, and a statement that the device is intended to be used by a physician trained in the clinical diagnosis and management of skin cancer ( e.g., a dermatologist);

(vii) Warnings to avoid unsafe exposure to any energy-emitting components of the device ( e.g., excluding use of the device on lesions close to the eye); and

(viii) Instructions for device maintenance and validated methods and instructions for reprocessing of any reusable components.

§ 878.3250 External facial fracture fixation appliance.

(a) Identification. An external facial fracture fixation appliance is a metal apparatus intended to be used during surgical reconstruction and repair to immobilize maxillofacial bone fragments in their proper facial relationship.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

§ 878.3300 Surgical mesh.

(a) Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

(b) Classification. Class II.

§ 878.3500 Polytetrafluoroethylene with carbon fibers composite implant material.

(a) Identification. A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.

(b) Classification. Class II.

§ 878.3510 Carbon dioxide gas controlled tissue expander.

(a) Identification. A carbon dioxide gas controlled tissue expander is a prescription device intended for temporary subcutaneous or submuscular implantation to stretch the skin for surgical applications, specifically to develop surgical flaps and additional tissue coverage. The device is made of an inflatable elastomer shell and is filled with carbon dioxide gas. The device utilizes a remote controller to administer doses of carbon dioxide gas from an implanted canister inside the device.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) In-vivo performance testing must be conducted to obtain the adverse event profile associated with use, and demonstrate that the device performs as intended under anticipated conditions of use.

(2) The patient-contacting components of the device must be demonstrated to be biocompatible.

(3) Performance data must demonstrate the sterility of patient-contacting components of the device.

(4) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:

(i) Cycle testing of expander showing that there are no leaks or tears after repeated cycling;

(ii) Mechanical assessment of implanted carbon dioxide (CO 2 ) canister including high impact testing;

(iii) Leak testing of expander showing that device does not leak CO 2 ;

(iv) Assessment of gas permeability during expansion and after full expansion; and

(v) Mechanical assessment of expander (tensile set, breaking force, shell joint test, and fused or adhered joint testing).

(5) Performance data must be provided to demonstrate the electromagnetic compatibility, electrical safety, and wireless compatibility of the device.

(6) Software verification, validation, and hazard analysis must be performed.

(7) Performance data must support shelf life by demonstrating continued sterility of the device or the sterile components, package integrity, and device functionality over the identified shelf life.

(8) Human factors testing and analysis must validate that the device design and labeling are sufficient for the end user.

(9) Physician labeling must include:

(i) The operating parameters, name, and model number of the indicated external dosage controller;

(ii) Information on how the device operates and the typical course of treatment;

(iii) Information on the population for which the device has been demonstrated to be effective;

(iv) A detailed summary of the device technical parameters; and

(v) Provisions for choosing an appropriate size implant that would be exchanged for the tissue expander.

(10) Patient labeling must include:

(i) Warnings, precautions, and contraindications, and adverse events/complications;

(ii) Information on how the device operates and the typical course of treatment;

(iii) The probable risks and benefits associated with the use of the device;

(iv) Post-operative care instructions; and

(v) Alternative treatments.

(11) Patient training must include instructions for device use, when it may be necessary to contact a physician, and cautionary measures to take when the device is implanted.

§ 878.3530 Silicone inflatable breast prosthesis.

(a) Identification. A silicone inflatable breast prosthesis is a silicone rubber shell made of polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane, that is inflated to the desired size with sterile isotonic saline before or after implantation. The device is intended to be implanted to augment or reconstruct the female breast.

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before November 17, 1999, for any silicone inflatable breast prosthesis that was in commercial distribution before May 28, 1976, or that has, on or before November 17, 1999, been found to be substantially equivalent to a silicone inflatable breast prosthesis that was in commercial distribution before May 28, 1976. Any other silicone inflatable breast prosthesis shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

§ 878.3540 Silicone gel-filled breast prosthesis.

(a) Identification —(1) Single-lumen silicone gel-filled breast prosthesis. A single-lumen silicone gel-filled breast prosthesis is a silicone rubber shell made of polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane. The shell either contains a fixed amount cross-linked polymerized silicone gel, filler, and stabilizers or is filled to the desired size with injectable silicone gel at time of implantation. The device is intended to be implanted to augment or reconstruct the female breast.

(2) Double-lumen silicone gel-filled breast prosthesis. A double lumen silicone gel-filled breast prosthesis is a silicone rubber inner shell and a silicone rubber outer shell, both shells made of polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane. The inner shell contains fixed amounts of cross-linked polymerized silicone gel, fillers, and stabilizers. The outer shell is inflated to the desired size with sterile isotonic saline before or after implantation. The device is intended to be implanted to augment or reconstruct the female breast.

(3) Polyurethane covered silicone gel-filled breast prosthesis. A polyurethane covered silicone gel-filled breast prosthesis is an inner silicone rubber shell made of polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane, with an outer silicone adhesive layer and an outer covering of polyurethane; contained within the inner shell is a fixed amount of cross-linked polymerized silicone gel, fillers, and stabilizers and an inert support structure compartmentalizing the silicone gel. The device is intended to be implanted to augment or reconstruct the female breast.

(b) Classification. Class III.

(c) Date premarket approval application (PMA) is required. A PMA is required to be filed with the Food and Drug Administration on or before July 9, 1991 for any silicone gel-filled breast prosthesis that was in commercial distribution before May 28, 1976, or that has on or before July 9, 1991 been found to be substantially equivalent to a silicone gel-filled breast prosthesis that was in commercial distribution before May 28, 1976. Any other silicone gel-filled breast prosthesis shall have an approved PMA in effect before being placed in commercial distribution.

§ 878.3550 Chin prosthesis.

(a) Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.

(b) Classification. Class II.

§ 878.3590 Ear prosthesis.

(a) Identification. An ear prosthesis is a silicone rubber solid device intended to be implanted to reconstruct the external ear.

(b) Classification. Class II.

§ 878.3610 Esophageal prosthesis.

(a) Identification. An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.

(b) Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”

§ 878.3680 Nose prosthesis.

(a) Identification. A nose prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the nasal dorsum.

(b) Classification. Class II.

§ 878.3720 Tracheal prosthesis.

(a) Identification. The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.

(b) Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”

§ 878.3750 External prosthesis adhesive.

(a) Identification. An external prosthesis adhesive is a silicone-type adhesive intended to be used to fasten to the body an external aesthetic restoration prosthesis, such as an artificial nose.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

§ 878.3800 External aesthetic restoration prosthesis.

(a) Identification. An external aesthetic restoration prosthesis is a device intended to be used to construct an external artificial body structure, such as an ear, breast, or nose. Usually the device is made of silicone rubber and it may be fastened to the body with an external prosthesis adhesive. The device is not intended to be implanted.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9. If the device is intended for use without an external prosthesis adhesive to fasten it to the body, the device is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

§ 878.3900 Inflatable extremity splint.

(a) Identification. An inflatable extremity splint is a device intended to be inflated to immobilize a limb or an extremity.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

§ 878.3910 Noninflatable extremity splint.

(a) Identification. A noninflatable extremity splint is a device intended to immobilize a limb or an extremity. It is not inflatable.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

§ 878.3925 Plastic surgery kit and accessories.

(a) Identification. A plastic surgery kit and accessories is a device intended to be used to reconstruct maxillofacial deficiencies. The kit contains surgical instruments and materials used to make maxillofacial impressions before molding an external prosthesis.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

§ 878.4010 Tissue adhesive.

(a) Tissue adhesive for the topical approximation of skin —(1) Identification. A tissue adhesive for the topical approximation of skin is a device intended for topical closure of surgical incisions, including laparoscopic incisions, and simple traumatic lacerations that have easily approximated skin edges. Tissue adhesives for the topical approximation of skin may be used in conjunction with, but not in place of, deep dermal stitches.

(2) Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: “Tissue Adhesive for the Topical Approximation of Skin.” See § 878.1(e) of this chapter for the availability of this guidance document.

(b) Tissue adhesive for non-topical use —(1) Identification. A tissue adhesive for non-topical use, including adhesives intended for use in the embolization of brain arteriovenous malformation or for use in ophthalmic surgery, is a device used for adhesion of internal tissues and vessels.

(2) Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 878.3 of this chapter.

§ 878.4011 Tissue adhesive with adjunct wound closure device for topical approximation of skin.

(a) Identification. A tissue adhesive with adjunct wound closure device intended for the topical approximation of skin is a device indicated for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. It may be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of wound during application of the liquid adhesive.

(b) Classification. Class II (special controls). The special control for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Tissue Adhesive with Adjunct Wound Closure Device Intended for the Topical Approximation of Skin.” See § 878.1(e) for the availability of this guidance document.

§ 878.4014 Nonresorbable gauze/sponge for external use.

(a) Identification. A nonresorbable gauze/sponge for external use is a sterile or nonsterile device intended for medical purposes, such as to be placed directly on a patient's wound to absorb exudate. It consists of a strip, piece, or pad made from open woven or nonwoven mesh cotton cellulose or a simple chemical derivative of cellulose. This classification does not include a nonresorbable gauze/sponge for external use that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9.

§ 878.4015 Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive.

(a) Identification. A wound dressing with pDADMAC additive is intended for use as a primary dressing for exuding wounds, 1st and 2d degree burns, and surgical wounds, to secure and prevent movement of a primary dressing, and as a wound packing.

(b) Classification. Class II (special controls). The special control is: the FDA guidance document entitled “Class II Special Controls Guidance Document: Wound Dressing With Poly (Diallyl Dimethyl Ammonium Chloride) (pDADMAC) Additive.” See § 878.1(e) for availability of this guidance document.

§ 878.4018 Hydrophilic wound dressing.

(a) Identification. A hydrophilic wound dressing is a sterile or non-sterile device intended to cover a wound and to absorb exudate. It consists of nonresorbable materials with hydrophilic properties that are capable of absorbing exudate (e.g., cotton, cotton derivatives, alginates, dextran, and rayon). This classification does not include a hydrophilic wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9.

§ 878.4020 Occlusive wound dressing.

(a) Identification. An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gases such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing. This classification does not include an occlusive wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9.

§ 878.4022 Hydrogel wound dressing and burn dressing.

(a) Identification. A hydrogel wound dressing is a sterile or non-sterile device intended to cover a wound, to absorb wound exudate, to control bleeding or fluid loss, and to protect against abrasion, friction, desiccation, and contamination. It consists of a nonresorbable matrix made of hydrophilic polymers or other material in combination with water (at least 50 percent) and capable of absorbing exudate. This classification does not include a hydrogel wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9.

§ 878.4025 Silicone sheeting.

(a) Identification. Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

§ 878.4040 Surgical apparel.

(a) Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.

(b) Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:

(i) The user contacting components of the device must be demonstrated to be biocompatible.

(ii) Analysis and nonclinical testing must:

(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and

(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.

(iii) NIOSH approved under its regulation.

(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

§ 878.4100 Organ bag.

(a) Identification. An organ bag is a device that is a flexible plastic bag intended to be used as a temporary receptacle for an organ during surgical procedures to prevent moisture loss.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

§ 878.4160 Surgical camera and accessories.

(a) Identification. A surgical camera and accessories is a device intended to be used to record operative procedures.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

§ 878.4165 Wound autofluorescence imaging device.

(a) Identification. A wound autofluorescence imaging device is a tool to view autofluorescence images from skin wounds that are exposed to an excitation light. The device is not intended to provide quantitative or diagnostic information.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

§ 878.4200 Introduction/drainage catheter and accessories.

(a) Identification. An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

§ 878.4300 Implantable clip.

(a) Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

(b) Classification. Class II.

§ 878.4320 Removable skin clip.

(a) Identification. A removable skin clip is a clip-like device intended to connect skin tissues temporarily to aid healing. It is not absorbable.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

§ 878.4340 Contact cooling system for aesthetic use.

(a) Identification. A contact cooling system for aesthetic use is a device that is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disruption of adipocyte cells intended for non-invasive aesthetic use.

(b) Classification. Class II (special controls). The special controls for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.

§ 878.4350 Cryosurgical unit and accessories.

(a) Identification —(1) Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.

(2) Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.

(3) Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.

(b) Classification. Class II.

§ 878.4360 Scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia.

(a) Identification. A scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia is a prescription device intended to reduce the frequency and severity of alopecia during chemotherapy in which alopecia-inducing chemotherapeutic agents are used.

(b) Classification —Class II (special controls). The special controls for this device are:

(1) Non-clinical performance testing must demonstrate that the device meets all design specifications and performance requirements, and that the device performs as intended under anticipated conditions of use. This information must include testing to demonstrate accuracy of the temperature control mechanism.

(2) Performance testing must demonstrate the electromagnetic compatibility and electrical safety of the device.

(3) Software verification, validation, and hazard analysis must be performed.

(4) The patient contacting components of the device must be demonstrated to be biocompatible. Material names must be provided.

(5) Labeling must include the following:

(i) A statement describing the potential risk of developing scalp metastasis.

(ii) Information on the patient population and chemotherapeutic agents/regimen for which the device has been demonstrated to be effective.

(iii) A summary of the non-clinical and/or clinical testing pertinent to use of the device.

(iv) A summary of the device technical parameters, including temperature cooling range and duration of cooling.

(v) A summary of the device- and procedure-related adverse events pertinent to use of the device.

(vi) Information on how the device operates and the typical course of treatment.

(6) Patient labeling must be provided and must include:

(i) Relevant contraindications, warnings, precautions, and adverse effects/complications.

(ii) Information on how the device operates and the typical course of treatment.

(iii) Information on the patient population for which there is clinical evidence of effectiveness.

(iv) The potential risks and benefits associated with use of the device.

(v) Postoperative care instructions.

(vi) A statement describing the potential risk of developing scalp metastasis.

§ 878.4370 Surgical drape and drape accessories.

(a) Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

(b) Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

§ 878.4371 Irrigating wound retractor device.

(a) Identification. An irrigating wound retractor device is a prescription device intended to be used by a surgeon to retract the surgical incision, to provide access to the surgical wound, to protect and irrigate the surgical wound, and to serve as a conduit for removal of fluid from the surgical wound.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The patient-contacting components of the device must be demonstrated to be biocompatible and evaluated for particulate matter.

(2) Performance data must demonstrate the sterility and pyrogenicity of the patient-contacting components of the device.

(3) Performance data must support shelf life by demonstrating continued functionality and sterility of the device over the identified shelf life.

(4) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing must:

(i) Characterize the tear resistance, tensile strength, and elongation properties of the barrier material;

(ii) Demonstrate that the liquid barrier material is resistant to penetration by blood, and is non-flammable;

(iii) Characterize the forces required to deploy the device;

(iv) Characterize the device's ranges of operation, including flow rates and maximum suction pressures;

(v) Demonstrate the ability of the device irrigation apparatus to maintain a user defined or preset flow rate to the surgical wound; and

(vi) Demonstrate the ability of the device to maintain user defined or preset removal rates of fluid from the surgical wound.

(5) The labeling must include or state the following information:

(i) Device size or incision length range;

(ii) Method of sterilization;

(iii) Flammability classification;

(iv) Non-pyrogenic;

(v) Shelf life; and

(vi) Maximum flow rate and suction pressure.

§ 878.4380 Drape adhesive.

(a) Identification. A drape adhesive is a device intended to be placed on the skin to attach a surgical drape.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a) Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

(b) Classification. Class II.

§ 878.4410 Low energy ultrasound wound cleaner.

(a) Identification. A low energy ultrasound wound cleaner is a device that uses ultrasound energy to vaporize a solution and generate a mist that is used for the cleaning and maintenance debridement of wounds. Low levels of ultrasound energy may be carried to the wound by the saline mist.

(b) Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner.” See § 878.1(e) for the availability of this guidance document.

§ 878.4420 Electrosurgical device for over-the-counter aesthetic use.

(a) Identification. An electrosurgical device for over-the-counter aesthetic use is a device using radiofrequency energy to produce localized heating within tissues for non-invasive aesthetic use.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Non-clinical performance data must demonstrate that the device meets all design specifications and performance requirements. The following performance characteristics must be tested: Over-heating, power accuracy radiofrequency, pulse cycle, waveform, pulse duration, and device characterization parameters.

(2) Label comprehension and self-selection performance evaluation must demonstrate that the intended over-the-counter users can understand the package labeling and correctly choose the device for the indicated aesthetic use.

(3) Usability performance evaluation must demonstrate that the over-the-counter user can correctly use the device, based solely on reading the directions for use, to treat the indicated aesthetic use.

(4) Clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use to achieve the intended aesthetic results.

(5) The patient-contacting components of the device must be demonstrated to be biocompatible.

(6) Instructions for cleaning the device must be validated.

(7) Performance data must be provided to demonstrate the electromagnetic compatibility and electrical safety, including the mechanical integrity, of the device.

(8) Software verification, validation, and hazard analysis must be performed.

(9) Labeling must include:

(i) Warnings, precautions, and contraindications to ensure the safe use of the device for the over-the-counter users.

(ii) A statement that the safety and effectiveness of the device's use for uses other than the indicated aesthetic use are not known.

(iii) A summary of the clinical information used to establish effectiveness for each indicated aesthetic usage and observed adverse events.

§ 878.4425 Skin patch for treatment of hyperhidrosis.

(a) Identification. A skin patch for treatment of hyperhidrosis is a prescription topical patch that utilizes a chemical reaction to generate thermal energy in situ for treatment of hyperhidrosis.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and evaluate:

(i) Reduction in hyperhidrosis using a validated measure;

(ii) All adverse events; and

(iii) Impact of residual chemical on the skin.

(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:

(i) Thermal reactivity of the active device component(s);

(ii) The total energy and energy flux (energy per unit area) of the device that is available to induce heating based on calorimetry; and

(iii) Characterization of the distribution and homogeneity of the chemical(s) on and within the device.

(3) The patient-contacting components of the device must be demonstrated to be biocompatible.

(4) Performance testing must support the shelf life of the device by demonstrating device functionality and package integrity over the labeled shelf life.

(5) Patient and physician labeling must include:

(i) A summary of the clinical performance testing conducted with the device;

(ii) A listing of known risks including local adverse events, systemic effects, and adverse changes in perspiration; and

(iii) Information about the known duration of effect.

(6) Physician labeling must also include:

(i) Instructions for safe disposal of the device; and

(ii) A shelf life.

§ 878.4430 Microneedling device for aesthetic use.

(a) Identification. A microneedling device for aesthetic use is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use. This classification does not include devices intended for transdermal delivery of topical products such as cosmetics, drugs, or biologics.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The technical specifications and needle characteristics must be identified, including needle length, geometry, maximum penetration depth, and puncture rate.

(2) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:

(i) Accuracy of needle penetration depth and puncture rate;

(ii) Safety features built into the device to protect against cross-contamination, including fluid ingress protection; and

(iii) Identification of the maximum safe needle penetration depth for the device for the labeled indications for use.

(3) Performance data must demonstrate the sterility of the patient-contacting components of the device.

(4) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the intended shelf life.

(5) Performance data must demonstrate the electrical safety and electromagnetic compatibility (EMC) of all electrical components of the device.

(6) Software verification, validation, and hazard analysis must be performed for all software components of the device.

(7) The patient-contacting components of the device must be demonstrated to be biocompatible.

(8) Performance data must validate the cleaning and disinfection instructions for reusable components of the device.

(9) Labeling must include the following:

(i) Information on how to operate the device and its components and the typical course of treatment;

(ii) A summary of the device technical parameters, including needle length, needle geometry, maximum penetration depth, and puncture rate;

(iii) Validated methods and instructions for reprocessing of any reusable components;

(iv) Disposal instructions; and

(v) A shelf life.

(10) Patient labeling must be provided and must include:

(i) Information on how the device operates and the typical course of treatment;

(ii) The probable risks and benefits associated with use of the device; and

(iii) Postoperative care instructions.

§ 878.4440 Eye pad.

(a) Identification. An eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

§ 878.4450 Nonabsorbable gauze for internal use.

(a) Identification. Nonabsorbable gauze for internal use is a device made of an open mesh fabric intended to be used inside the body or a surgical incision or applied to internal organs or structures, to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination. The device is woven from material made of not less than 50 percent by mass cotton, cellulose, or a simple chemical derivative of cellulose, and contains x-ray detectable elements.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

§ 878.4452 Nonabsorbable expandable hemostatic sponge for temporary internal use.

(a) Identification. A nonabsorbable expandable hemostatic sponge for temporary internal use is a prescription device intended to be placed temporarily into junctional, non-compressible wounds, which are not amenable to tourniquet use, to control bleeding until surgical care is acquired. The sponges expand upon contact with blood to fill the wound cavity and provide a physical barrier and pressure that facilitates formation of a clot. The device consists of sterile, nonabsorbable radiopaque compressed sponges and may include an applicator to facilitate delivery into a wound.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Performance data must demonstrate the biocompatibility of patient-contacting components.

(2) Performance data must demonstrate the sterility of patient-contacting components including endotoxin and pyrogenicity assessments.

(3) Performance data must support device stability by demonstrating continued sterility of the patient-contacting components of the device, package integrity, and device functionality over the requested shelf life.

(4) Assessment of material characteristics must be sufficient to support safety under anticipated conditions of use. Assessments must include the following:

(i) Material specifications.

(ii) Immunogenicity.

(iii) Viral inactivation for animal-derived materials.

(5) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:

(i) Absorption capacity.

(ii) Extent of swelling.

(iii) Mechanical properties.

(iv) Expansion force/pressure.

(v) Radiopacity.

(vi) Deployment/applicator functionality.

(6) In vivo performance data must demonstrate safe and effective use by verifying that the device performs as intended under anticipated conditions of use. Appropriate analysis/testing must demonstrate that the product: Controls bleeding, does not promote adverse local or systemic effects, and can be completely removed from the wound. The following performance characteristics must be tested:

(i) Deployment.

(ii) Control of bleeding.

(iii) Radiopacity.

(iv) Retrieval.

(v) Assessment of local and systemic effects.

(7) Human factors testing and analysis must validate that the device design and labeling are sufficient for appropriate use by emergency responders deploying the device as well as surgeons retrieving the device from wounds.

(8) Labeling must include:

(i) Specific instructions for deployment by emergency responders and retrieval by surgeons.

(ii) Warnings, cautions, and limitations needed for safe use of the device.

(iii) Information on how the device operates and the typical course of treatment.

(iv) A detailed summary of the in vivo and human factors testing pertinent to use of the device.

(v) Appropriate imaging information to ensure complete retrieval of device.

(vi) An expiration date/shelf life.